Specialized Workshop M2 - Monday April 13, 2026: 7am to 5:45pm
"AGENDA - Biomarkers Discovery, Development, Validation & Regulatory Approval
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| 07:00am-08:00am: |
Start your day at WRIB with Continental Breakfast |
Session 1: Latest Strategies for Biomarker Assays Bridging & Trending, Tissue Quantification and Range Definition
Special Session: ASK THE REGULATORS!
| -07:30pm: |
Regulatory Feedbacks on Submitted Studies and Inspection/Audit Outcomes on Biomarkers & CDx/BAV
Regulatory Panelists:
- Mr. Abbas Bandukwala (US FDA)
- Dr. Binsheng Gong (US FDA)
- Dr. Wenming Xiao (US FDA)
- Ms. Leslie Wagner (US FDA)
- Dr. Alessandra Buoninfante (EU EMA)
- Dr. Olga Kholmanskikh (Belgium FAMHP / EU EMA)
- Dr. Anna Nowocin (UK MHRA)
- Dr. Bradley Scott (Health Canada)
- Dr. Chad Irwin (Health Canada)
- Dr. Sarah Wassmer (Health Canada)
- Mr. Joao Tavares Neto (Brazil ANVISA)
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Session 2: Impact of Minor/Major Changes on Biomarker Assays Performance: Automation, Singlicate Analysis, Formats
Session 3: Advancements in Autoantibody, Influenza, Neurofilament Biomarker Assays
Session 4: Latest Developments in Biomarkers/CDx, IVDs and LDTs Regulatory Framework
Session 5: 2026 White Paper in Bioanalysis
| 07:30pm-08:05pm: |
"Recommendations on Biomarkers & Companion Diagnostics and Panel Discussions for 2026 White Paper in Bioanalysis"
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| 05:45pm-06:45pm |
Welcome Reception at Mark Twain Courtyard
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